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Last Updated: May 23, 2025

CLINICAL TRIALS PROFILE FOR AMINOCAPROIC ACID


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All Clinical Trials for Aminocaproic Acid

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00156520 ↗ Platelet Function And Aggregometry In Patients With Aortic Valve Stenosis Completed University of Rochester Phase 4 2005-03-01 It is known that patients with aortic stenosis, including those undergoing cardiac surgery for this problem, are prone to developing bleeding problems, particularly of the gastrointestinal tract. It is believed that the shear stress associated with blood flow through the abnormal aortic valve results in abnormal hemostasis. Abnormalities include increased proteolysis of the von Willebrand factor (vWF) and increased binding of the high molecular weight multimers of vWF to platelet membranes with subsequent inappropriate platelet aggregation. Thus, appropriate aggregation of circulating platelets is impaired. Cardiac surgery is associated with significant alterations in hemostasis. Patients undergoing cardiac surgery consume a significant percent of available blood products throughout the United States and are subjected to various and numerous risks associated with blood product transfusion. In addition, excessive postoperative bleeding is a common cause for the need to surgically re-explore the chest cavity in patients who have just undergone cardiac surgical procedures. Such additional surgery carries further cost and risk. Following surgical correction of aortic valve stenotic pathology, associated vWF abnormalities appear to reverse. However, this process can take several days. Although all cardiac surgical patients are at risk for postoperative bleeding, patients undergoing aortic valve surgery for aortic stenosis may be particularly at risk for this postoperative complication. In addition, patients with aortic valve stenosis who undergo noncardiac surgery may have a predisposition to bleeding because of similar underlying shear stress induced abnormal vWF and platelet function. The proposed study is a trial to evaluate the effectiveness of 2 different antifibrinolytic drugs in ameliorating the hemostatic defect associated with aortic stenosis. Aprotonin, an antifibrinolytic agent which also has platelet preserving actions4, will be compared to the currently used anti-fibrinolytic, epsilon aminocaproic acid (EACA).
NCT00223704 ↗ Bradykinin Receptor Antagonism During Cardiopulmonary Bypass Completed Vanderbilt University Phase 2/Phase 3 2006-05-01 Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary bypass (CPB). CPB is associated with significant morbidity including the transfusion of allogenic blood products, inflammation and hemodynamic instability. In fact, approximately 20% of all blood products transfused are associated with coronary artery bypass grafting procedures. Transfusion of allogenic blood products is associated with well-documented morbidity and increased mortality after cardiac surgery. Enhanced fibrinolysis contributes to increased blood product transfusion in the perioperative period. The current proposal tests the central hypothesis that endogenous bradykinin contributes to the hemodynamic, fibrinolytic and inflammatory response to CPB and that bradykinin receptor antagonism will reduce hypotension, inflammation and transfusion requirements. In SPECIFIC AIM 1 we will test the hypothesis that the fibrinolytic and inflammatory response to CPB differ during ACE inhibition and angiotensin II type 1 receptor antagonism. In SPECIFIC AIM 2 we will test the hypothesis that bradykinin B2 receptor antagonism attenuates the hemodynamic, fibrinolytic, and inflammatory response to CPB. In SPECIFIC AIM 3 we will test the hypothesis that bradykinin B2 receptor antagonism reduces the risk of allogenic blood product transfusion in patients undergoing CPB. These studies promise to provide important information regarding the effects of drugs that interrupt the RAS and generate new strategies to reduce morbidity in patients undergoing CPB.
NCT00223704 ↗ Bradykinin Receptor Antagonism During Cardiopulmonary Bypass Completed Vanderbilt University Medical Center Phase 2/Phase 3 2006-05-01 Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary bypass (CPB). CPB is associated with significant morbidity including the transfusion of allogenic blood products, inflammation and hemodynamic instability. In fact, approximately 20% of all blood products transfused are associated with coronary artery bypass grafting procedures. Transfusion of allogenic blood products is associated with well-documented morbidity and increased mortality after cardiac surgery. Enhanced fibrinolysis contributes to increased blood product transfusion in the perioperative period. The current proposal tests the central hypothesis that endogenous bradykinin contributes to the hemodynamic, fibrinolytic and inflammatory response to CPB and that bradykinin receptor antagonism will reduce hypotension, inflammation and transfusion requirements. In SPECIFIC AIM 1 we will test the hypothesis that the fibrinolytic and inflammatory response to CPB differ during ACE inhibition and angiotensin II type 1 receptor antagonism. In SPECIFIC AIM 2 we will test the hypothesis that bradykinin B2 receptor antagonism attenuates the hemodynamic, fibrinolytic, and inflammatory response to CPB. In SPECIFIC AIM 3 we will test the hypothesis that bradykinin B2 receptor antagonism reduces the risk of allogenic blood product transfusion in patients undergoing CPB. These studies promise to provide important information regarding the effects of drugs that interrupt the RAS and generate new strategies to reduce morbidity in patients undergoing CPB.
NCT00320619 ↗ Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery Completed National Heart, Lung, and Blood Institute (NHLBI) N/A 2000-09-01 Individuals who undergo spine surgery often have a significant loss of blood and may require multiple blood transfusions. Research has shown that epsilon-aminocaproic acid (EACA) may reduce the amount of blood lost during surgery, which would decrease the number of blood transfusions required. This study will evaluate the safety and effectiveness of EACA at reducing blood loss and the need for blood transfusions in individuals undergoing spine surgery.
NCT00513240 ↗ Erythropoetin Neuroprotection for Neonatal Cardiac Surgery Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 1/Phase 2 2006-09-01 Brain problems occur in neonatal open heart surgery with a frequency of 20-70%, seen on neurological examination, brain imaging such as magnetic resonance imaging (MRI), or long term development problems such as learning disorders and hyperactivity syndromes. This study aims to determine if erythropoetin, a natural hormone made in the body, protects the brain from damage when given in high doses before and during neonatal open heart surgery. We will use brain MRI, brain wave tests (EEG), neurological examination, and long term developmental outcome testing to see if erythropoetin is better than salt water injection (placebo) in protecting the brain.
NCT00513240 ↗ Erythropoetin Neuroprotection for Neonatal Cardiac Surgery Completed Texas Children's Hospital Phase 1/Phase 2 2006-09-01 Brain problems occur in neonatal open heart surgery with a frequency of 20-70%, seen on neurological examination, brain imaging such as magnetic resonance imaging (MRI), or long term development problems such as learning disorders and hyperactivity syndromes. This study aims to determine if erythropoetin, a natural hormone made in the body, protects the brain from damage when given in high doses before and during neonatal open heart surgery. We will use brain MRI, brain wave tests (EEG), neurological examination, and long term developmental outcome testing to see if erythropoetin is better than salt water injection (placebo) in protecting the brain.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Aminocaproic Acid

Condition Name

Condition Name for Aminocaproic Acid
Intervention Trials
Bleeding 3
Blood Loss 3
Blood Loss, Surgical 3
Craniosynostosis 2
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Condition MeSH

Condition MeSH for Aminocaproic Acid
Intervention Trials
Hemorrhage 16
Osteoarthritis 3
Blood Loss, Surgical 3
Craniosynostoses 2
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Clinical Trial Locations for Aminocaproic Acid

Trials by Country

Trials by Country for Aminocaproic Acid
Location Trials
United States 40
Egypt 4
Canada 2
Brazil 2
Mexico 2
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Trials by US State

Trials by US State for Aminocaproic Acid
Location Trials
New York 5
Illinois 3
Georgia 3
North Carolina 3
California 3
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Clinical Trial Progress for Aminocaproic Acid

Clinical Trial Phase

Clinical Trial Phase for Aminocaproic Acid
Clinical Trial Phase Trials
Phase 4 12
Phase 3 3
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Aminocaproic Acid
Clinical Trial Phase Trials
Completed 25
Unknown status 4
Recruiting 3
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Clinical Trial Sponsors for Aminocaproic Acid

Sponsor Name

Sponsor Name for Aminocaproic Acid
Sponsor Trials
NYU Langone Health 2
Duke University 2
Texas Children's Hospital 2
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Sponsor Type

Sponsor Type for Aminocaproic Acid
Sponsor Trials
Other 51
NIH 2
Industry 2
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Aminocaproic Acid: Clinical Trials, Market Analysis, and Projections

Overview of Aminocaproic Acid

Aminocaproic acid, also known by its brand name Amicar, is an antifibrinolytic agent derived from the amino acid lysine. It is used to induce clotting and prevent excessive bleeding in various clinical settings, including postoperative care, gynecological conditions, and certain types of hemorrhage[4].

Clinical Trials

Aminocaproic acid has been extensively studied in various clinical trials to assess its efficacy and safety.

  • Phase Trials: The drug has undergone multiple phase trials. As of the latest data, there have been 2 Phase 0 trials, 5 Phase 1 trials, 5 Phase 2 trials, 2 Phase 3 trials, and 9 Phase 4 trials[4].
  • Efficacy in Thrombocytopenia: Studies have shown that aminocaproic acid is effective in managing bleeding in patients with both immune and nonimmune thrombocytopenia. It has successfully controlled various types of hemorrhage, including vaginal, gastrointestinal, intracerebral, and cutaneous bleeding[1].
  • Postoperative Use: Clinical trials have demonstrated the drug's ability to reduce bleeding post-surgery, making it a valuable tool in surgical settings[4].

Mechanism of Action

Aminocaproic acid works by inhibiting plasminogen activators and, to a lesser degree, by antiplasmin activity. It binds reversibly to the kringle domain of plasminogen, preventing its activation to plasmin and thereby reducing fibrinolysis. This mechanism is crucial for its antifibrinolytic effects, particularly in preventing postoperative bleeding[4].

Market Analysis

Global Market Size and Growth

  • The global aminocaproic acid market was valued at approximately $2.21 billion in 2023 and is projected to reach $2.717 billion by 2030, growing at a CAGR of 3.0% during the forecast period of 2024-2030[2].
  • The broader antifibrinolytic market, which includes aminocaproic acid and other drugs like tranexamic acid, was valued at $15 billion in 2021 and is expected to reach $22.16 billion by 2029, growing at a CAGR of 5%[3].

Market Segmentation

  • By Type: The market is segmented based on the type of antifibrinolytic drug, with aminocaproic acid being one of the key segments[3].
  • By Application: Aminocaproic acid is used in various applications, including gynecology, gastrointestinal bleeding, hereditary angioedema, hemorrhage, and surgeries. The gynecologic segment, particularly for controlling menorrhagia, is a significant driver of market growth[3].
  • By Route of Administration: The drug can be administered orally or via injection, with each route having its own market share and growth prospects[3].
  • By End-Users: The primary end-users include hospitals, homecare settings, specialty centers, and others. Hospitals and specialty centers are major contributors to the market demand[3].

Regional Analysis

  • The market is segmented geographically into North America, Europe, Asia Pacific, Latin America, and other regions. Each region has its own market size, sales volume, and revenue forecasts from 2019 to 2030[2].

Market Drivers and Opportunities

Growing Demand in Trauma Centers

  • The increasing number of road accidents globally has led to a higher demand for antifibrinolytic agents in trauma centers, driving market growth[3].

Huge Demand for Gynecologic Syndromes

  • The use of aminocaproic acid and other antifibrinolytics to prevent heavy menstrual bleeding (menorrhagia) is a significant market driver[3].

Increasing Demand for Retail Pharmacies

  • The shift towards retail pharmacies and online pharmacies is expected to increase the accessibility and sales of aminocaproic acid, presenting new market opportunities[3].

Competitive Landscape

The global aminocaproic acid market is competitive, with several key players including:

  • Brilliant Pharma
  • Zhongbao Pharma
  • Shuguang Pharma
  • CR Group
  • Southwest Pharmaceutical
  • Yongan Pharma
  • SPH
  • Yuexing Pharma
  • Jimincare
  • Lanling Pharmaceutical
  • 3SBio Pharmaceutical Group
  • Fangda Group
  • Aurobindo Pharma
  • Agenix
  • Vertice Pharma
  • Pfizer
  • Baxter[2].

Key Takeaways

  • Aminocaproic acid is a safe and effective antifibrinolytic agent used to manage bleeding in various clinical settings.
  • The drug has undergone extensive clinical trials, demonstrating its efficacy in postoperative care and other bleeding disorders.
  • The global market for aminocaproic acid is projected to grow at a CAGR of 3.0% from 2024 to 2030.
  • Market growth is driven by increasing demand in trauma centers, gynecologic syndromes, and the expanding retail pharmacy segment.
  • The competitive landscape includes several major pharmaceutical companies.

FAQs

What is aminocaproic acid used for?

Aminocaproic acid is used to prevent excessive bleeding in various conditions, including postoperative care, gynecological disorders, and certain types of hemorrhage.

How does aminocaproic acid work?

Aminocaproic acid works by inhibiting plasminogen activators and antiplasmin activity, thereby reducing fibrinolysis and preventing excessive bleeding.

What are the key applications of aminocaproic acid?

Key applications include gynecology (e.g., menorrhagia), gastrointestinal bleeding, hereditary angioedema, hemorrhage, and surgeries.

What is the projected market size of aminocaproic acid by 2030?

The global aminocaproic acid market is projected to reach $2.717 billion by 2030.

Who are the major players in the aminocaproic acid market?

Major players include Brilliant Pharma, Zhongbao Pharma, Shuguang Pharma, CR Group, and several other pharmaceutical companies.

What are the main drivers of the aminocaproic acid market?

The main drivers include growing demand in trauma centers, huge demand for gynecologic syndromes, and increasing demand for retail pharmacies.

Sources

  1. Arch Intern Med. "Control of Bleeding in Patients With Immune and Nonimmune Thrombocytopenia." 1989.
  2. QY Research. "Global Aminocaproic Acid Market Research Report 2024."
  3. Data Bridge Market Research. "Global Antifibrinolytic Market – Industry Trends and Forecast to 2029."
  4. DrugBank. "Aminocaproic acid: Uses, Interactions, Mechanism of Action."
Last updated: 2025-01-02

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